The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-991-2013·Announced 2013-09-18

Beacon Hill Medical Pharmacy Recalls Compounded Progesterone/Testosterone Injection

Beacon Hill Medical Pharmacy is recalling compounded progesterone and testosterone injections due to FDA inspectional findings regarding sterility assurance.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.

Plain-English summary

Beacon Hill Medical Pharmacy, P.C., is recalling all presentations of PROG/TEST CYP 15/7.5 MG/ML OIL INJ SOLN. The product is a sterile, prescription-only compounded solution intended for intravenous and subcutaneous use only. The recall is being conducted by the firm, which operates as Rxtra Solutions in Southfield, Michigan.

The recall was initiated following FDA inspectional findings that raised concerns about quality control procedures. Specifically, the findings impacted the assurance of sterility for the product. The source text does not specify the number of units affected or the exact distribution dates, though code information indicates 05012013@23 and 06202013@20.

Consumers and healthcare providers who have this product should stop using it and contact their pharmacist or the recalling firm for instructions on return or disposal. The source text does not report any illnesses or injuries associated with the use of this product.

The recalled product

Product
PROG/TEST CYP 15/7.5 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
Manufacturer
Beacon Hill Medical Pharmacy, P.C.
Category
Drug — Compounded Injectable
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • 05012013@23
  • 06202013@20

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 86 recalled by Beacon Hill Medical Pharmacy, P.C. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 86 products in this recall →

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